ANDA 208764, held by Dr Reddys Labs SA. Exemestane.
As of Nov 13, 2026, ANDA 208764 (Exemestane), held by Dr Reddys Labs SA, was first approved by FDA on Aug 8, 2019, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 8, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Exemestane25MG · tablet;oral | Exemestane | Discontinued |
| Jul 8, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 8, 2019 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
